Zambon Receives European Commission Approval for Hopledo® to Treat Parkinson's Motor Fluctuations
Zambon has announced that the European Commission (EC) has granted marketing authorization for Hopledo® (modified-release levodopa/carbidopa). This approval is for the treatment of adult patients with Parkinson's disease experiencing moderate to severe motor fluctuations who have not been adequately stabilized with existing oral levodopa/dopa decarboxylase (DDC) inhibitor-based treatments. Hopledo® is a first-in-class oral formulation designed to provide both rapid onset of action and prolonged therapeutic benefit, aiming to maintain more stable levodopa plasma concentrations and extend symptom control. The EC's decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is supported by data from the Phase 3 RISE-PD trial. Zambon plans to begin a phased introduction of Hopledo® across European markets starting in October 2026. Hopledo®, previously known as IPX203, is already approved and marketed in the United States under th... 
